Gn Healthy Gums Mouthwash

Gn Healthy Gums Mouthwash
SPL v3
SPL
SPL Set ID 3e90abec-44f4-e378-e063-6294a90a50fb
Route
ORAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (1 mg)
Inactive Ingredients
Thyme Oil Menaquinone-7 Stevia Leaf Disodium Phosphate Menthol Peg-40 Hydrogenated Castor Oil Eucalyptus Oil Poloxamer 407 Peppermint Oil Citric Acid Xylitol Methyl Salicylate .alpha.-tocopherol, D- Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Cetylpyridinium Chloride 0.1%

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium Chloride 0.1%

Uses
  • Helps prevent gingivitis, an early form of gum disease, and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums
Section 51945-4

Warnings

Warnings

Directions

Adults and children 12 years of age and older: Vigorougly swish 20 mL (1 tablespoon) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.

Children 6 years to under 12 years: Supervise use.

Children under 6 years: Do not use.

Active Ingredient

Cetylpyridinium Chloride 0.1%

Other Information
  • This rinse is not intended to replace brushing or flossing
  • Do not use if printed safety seal on the bottle's neck is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients

Water, Glycerin, Xylitol, PEG-40 Hydrogenated Castor Oil, Poloxamer 407, Wintergreen Oil, Menthol, D-Alpha Tocopherol (Vitamin E), Stevia Leaf Extract, Disodium Phosphate, Citric Acid, Eucalyptus Oil, Peppermint Oil, Thyme Oil, Menaquinone-7 (Vitamin K2 MK-7)

Stop Use and Ask A Dentist If
  • Gingivitis, bleeding, or redness persists for more than 2 weeks
  • You have painful or swollen gums, pus from the gum line, loose teeth, or icnreasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease
Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses
  • Helps prevent gingivitis, an early form of gum disease, and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums
Section 51945-4 (51945-4)

Purpose

Antigingivitis/Antiplaque

Warnings

Warnings

Directions

Adults and children 12 years of age and older: Vigorougly swish 20 mL (1 tablespoon) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.

Children 6 years to under 12 years: Supervise use.

Children under 6 years: Do not use.

Active Ingredient (Active ingredient)

Cetylpyridinium Chloride 0.1%

Other Information (Other information)
  • This rinse is not intended to replace brushing or flossing
  • Do not use if printed safety seal on the bottle's neck is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Xylitol, PEG-40 Hydrogenated Castor Oil, Poloxamer 407, Wintergreen Oil, Menthol, D-Alpha Tocopherol (Vitamin E), Stevia Leaf Extract, Disodium Phosphate, Citric Acid, Eucalyptus Oil, Peppermint Oil, Thyme Oil, Menaquinone-7 (Vitamin K2 MK-7)

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • Gingivitis, bleeding, or redness persists for more than 2 weeks
  • You have painful or swollen gums, pus from the gum line, loose teeth, or icnreasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease
Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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